Status:
COMPLETED
12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia
Lead Sponsor:
Veloxis Pharmaceuticals
Conditions:
Dyslipidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia
Detailed Description
POPULATION: Subjects with mixed dyslipidemia (non-HDL cholesterol \> 130 mg/dL and TG ≥ 150 mg/dL and ≤ 500 mg/dL) who completed the double-blind study (LCP-AtorFen-2001; NCT00504829), met the enroll...
Eligibility Criteria
Inclusion
- Subject has successfully completed the double-blind study (LCP-AtorFen-2001; NCT00504829).
- Subject has confirmed his or her willingness to participate in this study after being informed of all aspects of the study by voluntarily signing and dating an informed consent form in accordance with Good Clinical Practice (GCP).
Exclusion
- Study drug compliance \<70% in the double-blind study.
- Any ongoing serious adverse event, or any ongoing non-serious moderate or severe adverse event from the double-blind study that is rated as possibly, probably or definitely related to study drug.
- Resting blood pressure \>/=160 mm Hg systolic and/or \>/=100 mm Hg diastolic.
- Symptoms of unexplained muscle pain, tenderness or weakness (i.e., signs indicative of possible myopathy), or any diagnosis of myopathy or rhabdomyolysis.
- Any clinically significant change in physical exam or electrocardiogram from Visit 2 to Visit 6 of the double-blind study.
- Any clinically significant change from Visit 1 to Visit 6 of the double-blind study in medical history including, but not limited to: a diagnosis of insulin-dependent diabetes mellitus (DM); poorly controlled DM; poorly controlled hypertension; significant renal, pulmonary, hepatic, biliary, or gastrointestinal disease; cancer (except non-melanoma skin cancer); and epilepsy.
- Unwilling to abstain from medications, supplements, ingredients and herbal therapies that were excluded in the double-blind study and continue to be excluded in the open-label study.
- Women who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential (not surgically sterilized between menarche and menopause) who are not using a medically approved method of contraception.
- Other exclusion conditions might apply.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00664859
Start Date
October 1 2007
End Date
February 1 2009
Last Update
March 24 2020
Active Locations (1)
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1
Radiant Research, 515 N State St, Suite 2700
Chicago, Illinois, United States, 60610